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Clinical Trials Framework and Standard Operating Procedures (SOPs) Resource Hub

Welcome to Department of Medicine's Clinical Trials Framework and Standard Operating Procedures (SOPs) Resource Hub. This page outlines our structured approach to supporting and streamlining clinical research, fostering compliance, and ensuring study success across the department.

Overview of Clinical Trials Framework

Our clinical research framework is built around four key pillars that support efficient and high-quality clinical trial conduct.

DOM Protocol Review Committee

This committee evaluates the risk and feasibility of higher-risk clinical trials. They review medium- and high-risk studies before they are activated, offering recommendations on feasibility and strategies to mitigate potential risks. They also ensure ongoing monitoring of feasibility after a study is active.

Key Policy: Initial Feasibility Policy

(Guides assessment at study intake)

Enhanced Clinical Trial Activities

This section focuses on initiatives designed to speed up study start-up and streamline internal processes. Key components include the universal adoption of OnCore for trial management, integration of digital tools like e-Consent and e-Regulatory systems, and leveraging automated tools like EPIC and StudyPages for participant recruitment.

Key Policy: OnCore Implementation SOP

(Details department-wide expectations for OnCore usage)

Clinical Research Leadership Committee

This committee provides high-level strategic direction and policy oversight for departmental clinical research. They review the feasibility of studies, both ongoing and new, and are responsible for implementing and reviewing overarching standard operating procedures (SOPs).

Key Policy: Ongoing Feasibility Policy

(Ensures continued feasibility monitoring post-activation)

Oversight Meetings

These are bi-monthly meetings involving Principal Investigators (PIs) and study coordinators. The main goals are to discuss recruitment progress and challenges, promote diverse participant enrollment using available institutional tools, and share best practices among teams to enhance overall study success.

Key Policy: PI Clinical Trial Oversight and Accountability Policy

(Defines expectations and structure for PI oversight
through a structured monthly review)

Resources & Tools

Clinical Research Resource: Commonly used resources at the University of Rochester to aide in researchers' and their study team’s ability to implement and perform their clinical trials.
Research Administration: List of division research administrators and/or clinical research managers
Faculty Research Delegates: List of representatives of basic science and clinical research across the Department of Medicine
Research Leadership Team

Contact & Support

Have questions or need support? Reach out to our Clinical Research Operations Team:

Valentina Kutyifa, Vice Chair for Clinical Research Valentina_Kutyifa@urmc.rochester.edu
Stefanie Fingler, Director of Research Operations Stefanie_Fingler@urmc.rochester.edu
Kari Steinmetz, Assistant Director Clinical Research Kari_Steinmetz@urmc.rochester.edu